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Recombinant DNA

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Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...

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Recombinant factor IX for clinical and research use.

Paul E Monahan¹, Jorge Di Paola

¹Department of Pediatrics, Gene Therapy Center, Harold R. Roberts Comprehensive Hemophilia Treatment Center, University or North Carolina at Chapel Hill, Chapel Hill, NC 27599-7236, USA. Paul_Monahan@med.unc.edu

Seminars in Thrombosis and Hemostasis

|July 16, 2010

Summary

Recombinant factor IX (FIX) therapy has improved hemophilia B safety. Novel FIX therapies engineered using recombinant DNA technology show promise for enhancing patient quality of life.

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Last Updated: Jun 10, 2026

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Extracellular Vesicle Tissue Factor Activity Assay

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Published on: December 29, 2023

Area of Science:

Biochemistry
Hematology
Molecular Biology

Background:

The introduction of recombinant factor IX (FIX) significantly enhanced safety in hemophilia B therapy by eliminating risks associated with plasma-derived clotting factors.
Recombinant DNA technology has been instrumental in understanding the function of FIX and its domains in coagulation.

Purpose of the Study:

To review the current recombinant FIX product.
To focus on novel FIX therapies developed through recombinant DNA technology.
To assess the potential of these new therapies to improve the quality of life for hemophilia B patients.

Main Methods:

Review of existing literature on recombinant factor IX (FIX) therapy.
Analysis of research utilizing recombinant DNA techniques to study FIX.
Examination of ongoing clinical trials for novel FIX therapies.

Main Results:

Recombinant FIX products offer improved safety profiles compared to plasma-derived factors.
Ongoing research and development are yielding a diverse range of novel FIX therapies.
Early indications suggest these novel therapies hold significant potential for improving patient outcomes.

Conclusions:

Recombinant DNA technology has revolutionized hemophilia B treatment, moving beyond safety enhancements to therapeutic innovation.
Novel recombinant FIX therapies are progressing towards clinical application, offering hope for better quality of life.
Continued research in this area is crucial for optimizing hemophilia B management.